CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 225 target
Drug / intervention
LNP023drug
Likely dose
Not stated in record
Key inclusion· 1
  • ✓Completed treatment period in CLNP023X2202, CLNP023B12301, or CLNP023B12302 study
Key exclusion· 6
  • ✕Severe concurrent comorbidities including advanced cardiac disease (NYHA class IV), severe pulmonary arterial hypertension (WHO class IV)
  • ✕Illness or medical condition likely to prevent safe tolerance of LNP023 or compliance with study requirements
  • ✕Active systemic bacterial, viral, or fungal infection within 14 days prior to screening
  • ✕Fever ≥38°C (100.4°F) within 7 days prior to screening

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03955445
NCT03955445Phase 3RecruitingOn TrackUpdated 2mo ago
Long Recruiting
CompareCT.gov

An Open-label, Non-randomized Extension Study to Evaluate the Long-term Efficacy, Safety and Tolerability of Iptacopan (LNP023) in C3 Glomerulopathy or Idiopathic Immune-complex-membranoproliferative Glomerulonephritis

Novartis Pharmaceuticals·interventional·Posted May 20, 2019·Updated Apr 14, 2026

In Brief

A Phase 3 clinical trial evaluating LNP023 for C3 Glomerulopathy and Immune-complex-membranoproliferative Glomerulonephritis. Currently recruiting, targeting 225 participants across 50 sites in 17 countries.

Detailed Summary

This is an open-label extension study to evaluate the long-term efficacy, safety and tolerability of iptacopan in subjects with C3 glomerulopathy or idiopathic immune-complex-membranoproliferative glomerulonephritis

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsC3 Glomerulopathy, Immune-complex-membranoproliferative Glomerulonephritis
CountriesArgentina, Brazil, Canada, China, Czechia, France, Germany, Greece, Israel, Italy, Japan, Netherlands, Spain, Switzerland, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3Recruiting
201920202021202220232024202520262027202820292030203120322033203420352036
First PostedMay 20, 2019
Enrollment StartOct 3, 2019
Primary CompletionMay 30, 2036
TodayJul 2, 2026
Enrollment to primary: 16.7 yearsPosted 7.1 years agoPrimary completion in 9.9 years

Interventions

LNP023drug

LNP023 capsules